Single incision laparoscopic tissue retrieval system

ABSTRACT

A tissue retrieval system can include a tissue retrieval bag with an elongate profile. The tissue retrieval bag can have a relatively large volume, but be rollable to a stowed configuration to fit in a relatively small diameter introducer. The tissue retrieval system can include one or more support arms coupled to the tissue retrieval bag, the support arms biased to position the tissue retrieval bag in an access position once deployed from the introducer. A tissue retrieval system can have a hybrid tissue retrieval bag including material properties that vary along the depth of the bag from an open end to a closed end. A tissue retrieval bag can be used in conjunction with an introducer, or as a stand alone tissue retrieval bag.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/275,911 entitled “SINGLE INCISION LAPAROSCOPIC TISSUE RETRIEVALSYSTEM,” filed Feb. 14, 2019, currently pending, which is a continuationof U.S. patent application Ser. No. 14/715,086 entitled “SINGLE INCISIONLAPAROSCOPIC TISSUE RETRIEVAL SYSTEM,” filed May 18, 2015, which issuedas U.S. Pat. No. 10,245,053, which is a continuation of U.S. patentapplication Ser. No. 12/902,055 entitled “SINGLE INCISION LAPAROSCOPICTISSUE RETRIEVAL SYSTEM,” filed Oct. 11, 2010, which issued as U.S. Pat.No. 9,033,995, and which claims the benefit of U.S. Provisional PatentApplication No. 61/389,101 entitled “TISSUE RETRIEVAL SYSTEM WITH HYBRIDRETRIEVAL BAG,” filed Oct. 1, 2010, and U.S. Provisional PatentApplication No. 61/250,364, entitled “SINGLE INCISION LAPAROSCOPICTISSUE RETRIEVAL SYSTEM,” filed Oct. 9, 2009. The above-referencedapplications are incorporated by reference herein in their entireties.

BACKGROUND OF THE INVENTION Field of the Invention

The present application relates generally to apparatuses and methods forcapturing and retrieving tissue from body cavities and in particular toa specimen retrieval bag device.

Description of the Related Art

Laparoscopic surgery is typically performed through trocars, whichprovide access across the abdominal wall and into the abdominal cavity.In some of surgeries, tissue disposed within the abdominal cavity is cutand removed from the body. However, removal of such tissue from the bodymay prove difficult due to the limited confines inherent withlaparoscopic surgery and the available laparoscopic surgicalinstruments. For example, to reduce the invasiveness to a patient, itcan be desirable to introduce all of the surgical instruments through asingle laparoscopic port having a relatively small size. Also, removedtissue may include an infected or cancerous mass or organ, as well asblood, bile and other liquids, all referred to herein as tissue, whichmay pose infection issues or other complications if left within thebody.

It is desirable to grasp, capture, retain and enclose this tissue whilein the body cavity, and then remove the enclosed tissue through thetrocar or incision. Containment of the tissue as quickly as possiblewith minimal disturbance to the surgical site is also desirable. Agenerally compact and single unit device would also prove desirable asdevices generally bulky and complicated have several shortcomings andlack optimal efficiency in particular with the limited space inoperating rooms and access ports in the body cavity.

SUMMARY OF THE INVENTION

In certain embodiments, a tissue retrieval system is provided herein.The tissue retrieval system comprises an elongate introducer, a tissueretrieval bag, and an actuator. The elongate introducer has a hollowlumen formed therein. The tissue retrieval bag has a proximal end, adistal end, and an opening. The tissue retrieval bag has an elongateprofile such that the opening is positioned adjacent the proximal endand the tissue retrieval bag comprises a distal portion extending fromthe opening towards the distal end of the tissue retrieval bag. Theactuator extends at least partially into the hollow lumen of theintroducer. The tissue retrieval bag is actuatable by the actuator froma stowed position in which the tissue retrieval bag is positioned withinthe hollow lumen of the introducer to an open position in which thetissue retrieval bag is substantially outside the introducer.

In certain embodiments, a tissue retrieval system is provided herein.The tissue retrieval system comprises an introducer, a tissue retrievalbag, and an actuator. The introducer is sized and configured to bereceived in a trocar, the trocar having a diameter of less than about 7mm. The introducer has a hollow lumen formed therein. The tissueretrieval bag has a volume of greater than approximately 100 mL. Thetissue retrieval bag has a stowed configuration in which it ispositionable within the hollow lumen of the introducer and an openconfiguration. The actuator is operable to advance the tissue retrievalbag from the stowed configuration within the introducer to the openconfiguration.

In certain embodiments, a tissue retrieval system is provided herein.The tissue retrieval system comprises an elongate tubular member, atissue retrieval bag, and a support arm. The elongate tubular member hasa passage formed therein. The elongate tubular member has a centrallongitudinal axis. The tissue retrieval bag has a stowed configurationin which the tissue retrieval bag is positionable within the passage ofthe elongate tubular member and an open configuration. The support armis coupled to the tissue retrieval bag. The support arm is biased in afirst direction radially outward from the central longitudinal axis anda second direction transverse to the central longitudinal axis toposition the tissue retrieval bag in the open configuration in an accessposition.

In certain embodiments, a tissue retrieval bag is provided herein. Thetissue retrieval bag comprises a film material. The film material has aproximal end, a distal end, and a rim defining an opening. The openinghas a longitudinal axis. The opening is positioned adjacent the proximalend. The tissue retrieval bag comprises an elongate profile defined by adistal portion of the tissue retrieval bag extending distally of theopening with respect to the longitudinal axis.

In certain embodiments, a tissue retrieval device comprises a retrievalbag. The retrieval bag has an open end and a closed end. The retrievalbag has a first portion adjacent the open end, a second portion adjacentthe closed end, and a joint coupling the first portion to the secondportion. The first portion of the retrieval bag has a first complianceand the second portion of the retrieval bag has a second compliance, thefirst compliance being greater than the second compliance.

In certain embodiments, a tissue retrieval device comprises a thin filmbag. The thin film bag has an open end and a closed end. The thin filmbag comprises a first portion adjacent the open end and a second portionadjacent the closed end. The first portion and the second portion areformed of a film material. The first portion of the thin film bag has afirst thickness and the second portion of the thin film bag has a secondthickness, the first thickness is less than the second thickness.

In certain embodiments, a tissue retrieval device comprises a tissue baghaving an open end, a closed end and an interior. The tissue bagcomprises a first portion adjacent the open end, and a second portionadjacent the closed end. The second portion comprises a first layer, asecond layer, a space between the first and second layer, and at leastone vent fluidly coupling the space to ambient conditions exterior tothe tissue bag.

In certain embodiments, a tissue retrieval device comprises a tissue baghaving an open end and a closed end. The tissue bag comprises a cuffportion adjacent the open end, a first body portion between the cuffportion and a second body portion, and the second body portion adjacentthe closed end. The cuff portion has a first compliance. The first bodyportion of the tissue bag has a second compliance. The second bodyportion of the tissue bag has a third compliance. The first complianceis greater than the second compliance, and the second compliance isgreater than the third compliance.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of an embodiment of tissue retrieval system;

FIG. 2 is a side view of the tissue retrieval system of FIG. 1 with theretrieval bag deployed;

FIG. 3 is a top view of the tissue retrieval system of FIG. 1 with theretrieval bag deployed;

FIG. 4A is a side view of the tissue retrieval bag of the tissueretrieval system of FIG. 1;

FIG. 4B is a side view of an embodiment of guide bead for the tissueretrieval bag of the tissue retrieval system of FIG. 1;

FIG. 4C is a front view of an embodiment of introducer tube of thetissue retrieval system of FIG. 1;

FIG. 4D is a partial cut away view of the introducer tube of FIG. 4C;

FIG. 5 is a side view of one support arm of the tissue retrieval systemof FIG. 1;

FIG. 6 is a top view of the support arm of FIG. 5;

FIG. 7 is a top view of an embodiment of tissue retrieval bag having anelongate profile and hybrid construction in a partially-formed state;

FIG. 8 is a side view of the tissue retrieval bag of FIG. 7 in afully-formed state;

FIG. 9 is a top view of an embodiment of cuff reinforcement tab for thetissue retrieval bag of FIGS. 7-8;

FIG. 10 is a perspective view of an embodiment of tissue retrievalsystem including an embodiment of hybrid tissue retrieval bag;

FIG. 11 is a side view of one embodiment of hybrid tissue retrieval bag;

FIG. 12 is a side view of one embodiment of hybrid tissue retrieval bag;

FIG. 13 is a side view of one embodiment of hybrid tissue retrieval bag;

FIG. 14 is a side view of one embodiment of hybrid tissue retrieval bag;and

FIG. 15 is a side view of one embodiment of hybrid tissue retrieval bag.

DETAILED DESCRIPTION OF THE INVENTION

With reference to FIG. 1, an embodiment of tissue retrieval system 10 isillustrated. The illustrated tissue retrieval system can be used forcontaining and withdrawing excised tissue specimens from within a bodycavity. For example, in some embodiments, the tissue retrieval systemcan be used to remove a patient's gallbladder from the patient'sabdominal cavity. Thus, advantageously, the tissue retrieval systemsdiscussed herein provide an easy to use tissue retrieval system whicheffectively contains excised tissue specimens to prevent loss orspillage of tissue specimens into a body cavity, and to protect the bodywall access port site from contamination with the excised tissuespecimens during withdrawal of the tissue specimens from within the bodycavity.

With continued reference to FIG. 1, the tissue retrieval system 10 isillustrated in a non-deployed or non-activated initial condition. In theillustrated embodiment, the tissue retrieval system has an introducer 3and an actuator or actuation rod 7. The introducer 3 in one aspect has atubular configuration with a hollow lumen and a handle assembly 5extending from a proximal end of the introducer 3. In some embodiments,the introducer 3 can be sized and configured for placement through astandard-size trocar. For example, it can be desirable that theintroducer 3 can be sized as a 5 mm laparoscopic surgical instrument tobe introduced through relatively small diameter trocars such as 5-7 mmtrocars. In other embodiments, the introducer 3 can be sized as a 10 mmlaparoscopic surgical instrument. In some embodiments, the introducer 3can have a non-standard size for application at a specific location. Insome embodiments, the tissue retrieval system 10 can include arelatively long introducer, such as, for example, a 45 cm longintroducer 3 to improve access to the surgical site.

The handle assembly 5 of the illustrated embodiment can comprise acompact handle member that can be adapted for placement adjacent othersurgical instruments in a single port laparoscopic surgical site. Thus,in some embodiments, the tissue retrieval system is adapted to beutilized during single incision laparoscopic procedures. In otherembodiments, the handle assembly can include a pair of finger loops orgrips formed with or otherwise coupled to the handle assembly 5 that canbe utilized to hold or stabilize the introducer 3 as desired.

In the illustrated embodiment of tissue retrieval system 10, theintroducer 3 has a proximal end and a distal end that are generallyopen, which can facilitate access to the hollow lumen. As illustrated,the actuator rod 7 extends into the hollow lumen from the open proximalend thereof, and at least a portion of the actuator rod 7 is slidablymovable within the hollow lumen of the introducer 3. As furtherdiscussed with reference to FIGS. 2 and 3, with the tissue retrievalsystem 10 in the initial configuration, a tissue retrieval bag 20 in astowed configuration can be positioned in the hollow lumen of theintroducer 3. The actuator rod 7 in one aspect has a handle 9 extendingfrom a proximal end thereof. The handle 9 provides a graspable portionof the device to control or facilitate movement of the actuator rod 7relative to the introducer 3 between the initial condition of the tissueretrieval system 10 (illustrated in FIG. 1), and a deployed condition ofthe tissue retrieval system (illustrated in FIGS. 2-3).

With reference to FIGS. 2 and 3, the tissue retrieval system can includea retrieval bag 20 that is deployable from the distal end of theintroducer 3 which can be used as a receptacle for tissue specimens.After insertion of tissue specimens into the retrieval bag 20, theretrieval bag can then be cinched closed to prevent spillage of itscontents and to prevent contamination of the body cavity and body cavitywall during withdrawal of the retrieval bag 20 from within the bodycavity.

With reference to FIGS. 2, 3, and 4A, in some embodiments, the tissueretrieval system includes a retrieval bag 20 sized and configured to becontained within a relatively small (such as, for example, a 5-7 mm)diameter introducer tube while providing a retrieval bag with a similarsize and volume as laparoscopic retrieval bags for use with 10 mmtrocars. Advantageously, such a retrieval bag 20 can facilitate variouslaparoscopic surgical procedures with the use of relatively small singleincision site surgical access points.

With continued reference to FIGS. 2, 3, and 4A, in the illustratedembodiment, the tissue retrieval bag 20 has a distal end 24 opposite aproximal end 22. The illustrated tissue retrieval bag 20 includes a rim26 defining an opening adjacent the proximal end 22 into the tissueretrieval bag 20, while the distal and 24 of the tissue retrieval bag 20is closed. Thus, in the illustrated embodiment, the tissue retrieval bag20 has an elongate profile, with a portion of the tissue retrieval bag20 extending distally from the rim 26 and the opening. The distallyextending portion of the retrieval bag diverges at an angle transverseto the rim 26 of the bag 20.

Advantageously, this elongate profile allows the tissue retrieval bag 20to have a relatively small outer diameter when in a stowed configuration(FIG. 1), while having a relatively large volume in a deployedconfiguration (FIGS. 2, 3, and 4A). Thus, the tissue retrieval bag 20,in the stowed configuration, can fit within a relatively small diameterintroducer tube 3. With reference to FIG. 4A, in order to position thetissue retrieval bag 20 in the stowed configuration, the tissueretrieval bag 20 can be rolled about an axis generally parallel to alongitudinal axis defined by the rim 26 and the opening of the bag.Thus, in the stowed configuration, the distal end 24, and thedistal-extending portion of the tissue retrieval bag 20 is positionedlongitudinally distally of the rim 26 and the opening with respect tothe axis defined by the rim 26. The tissue retrieval bag 20 in thestowed configuration can be stored within the introducer tube 3. Thecross-sectional area at any point along the length of the rolledretrieval bag with respect to the longitudinal axis defined by the rim26 is equivalent to or smaller than the cross-sectional area of arelatively small introducer tube, such as a 5-7 mm introducer tube.Likewise, the cross-sectional area at any point along the axis of therolled retrieval bag 20 is decreased as compared to prior retrieval bagsof approximately the same volume.

In one embodiment, the tissue retrieval bag 20 is sized such that thevolume of the retrieval bag is approximately 180 mL and the tissueretrieval bag 20 in the stowed configuration fits within a 5-7 mm trocarintroducer. In some embodiments, the volume of the tissue retrieval bagis greater than approximately 100 mL. Accordingly, a ratio of the volumeof the retrieval bag to its stowed diameter can be relatively high, inthe exemplary embodiment, approximately 26-36 mL/mm. In otherembodiments, the tissue retrieval bag 20 can be sized such that thevolume is between about 50 mL and 400 mL, desirably between about 100 mLand 350 mL, and more desirably between about 150 mL and 200 mL. In someembodiments, the volume of the retrieval bag 20 fit within apredetermined size trocar can be increased by further elongating the bagto enable a greater amount of tissue to be placed within the bag. Forexample, some embodiments of tissue retrieval bag for placement within a5-7 mm trocar introducer can have a first length between the proximalend 22 and the distal end 24 and a first volume, while other embodimentsof tissue retrieval bag for placement within a 5-7 mm trocar introducercan have a second length between the proximal end 22 and the distal end24 and a second volume, where the first length is smaller than thesecond length and the first volume is smaller than the second volume.

In one embodiment, the retrieval bag 20 is configured from 4.2 mil(0.0042″) thick polyurethane film. In some embodiments, the thickness ofthe polyurethane film can be greater than or less than 4.2 mil, such as,for example for use in extracting tissue of a relatively high or lowweight. In some embodiments, the retrieval bag can be formed from avariety of materials including polyurethane, polyethylene, polyimide,ripstop Nylon®, polyester, and Mylar®. In some embodiments, theretrieval bag can be formed from laminated materials such aspolyurethane coated ripstop Nylon, silicone coated ripstop Nylon,polyurethane coated ripstop polyester, silicone coated ripstoppolyester, polyurethane coated taffeta, and polyurethane coated spandex.The thicknesses of any of these materials can be chosen based, at leastpartially, on considerations of tissue weight to be carried by thetissue retrieval bag and outer diameter of the tissue retrieval bag in astowed configuration.

As further discussed below with respect to FIGS. 7-15, in someembodiments, the tissue retrieval bag 20 can have hybrid properties—thatis material properties that vary from the open end of the bag to theclosed end of the bag. For example, in some embodiments, the tissueretrieval bag 20 can be formed with two different thicknesses of thesame film material. For example, a portion of the tissue retrieval bag20 adjacent the distal end of the retrieval bag can be formed with arelatively thick film and have a relatively low compliance while theremainder of the retrieval bag can be formed with a thinner film andhave a relatively higher compliance. By incorporating a film with anincreased thickness in the distal portion of the retrieval bag, thetensile and burst strengths of the retrieval bag can be increased, or atissue retrieval bag having equivalent tensile and burst strengths canhave a smaller outer diameter in the stowed configuration.

In some embodiments, the tissue retrieval bag can be formed with twodifferent materials. For example, a portion of the tissue retrieval bagadjacent the distal end can be formed from one material having arelatively high tensile strength while the remainder of the retrievalbag can be formed from a different material having a relatively lowertensile strength. For example, the distal portion of the retrieval bagcan be formed from a polyurethane and ripstop Nylon laminate while theremainder of the retrieval bag can be formed from a polyurethane film.In some embodiments, the material utilized for the distal tip of theretrieval bag can have an increased thickness as compared to thematerial utilized for the remainder of the retrieval bag. Byincorporating different materials in different areas of the retrievalbag, the tensile and burst strengths of the retrieval bag can beincreased, or a tissue retrieval bag having equivalent tensile and burststrengths can have a smaller outer diameter in the stowed configuration.

With reference to FIGS. 2, 3, and 4A, the tissue retrieval bag caninclude a non-continuous cuff 30 for retaining a cord 32 that is usedfor cinching the retrieval bag closed and for withdrawing the retrievalbag 20 through a body wall. During withdrawal of the retrieval bag 20through a body wall, tensile stresses are concentrated at the distalportion 28 of the rim 26. This concentration of stresses can beespecially pronounced in the withdrawal of the retrieval bag 20 througha relatively small diameter incision or access device. Therefore, insome embodiments, it can be desirable to provide the retrieval bag 20with a reinforced distal cuff 30 having a reinforced section at a distalportion 28 of the rim 26 or opening. The cuff 30 can include one or moreloops 34 formed at the distal portion 28 of the rim 26 for retaining thecord 32. The loop 34 can consist of a single layer of film, or cancomprise multiple layers of film to provide the retrieval bag with areinforced cuff. The number of layers and thickness of each layer can besized to provide a predetermined tensile strength for the retrieval bag.In other embodiments, it can be desirable that the retrieval bag isformed with a continuous cuff rather than a reinforced cuff 30 with oneor more layers of loops 34 such that the cuff is substantiallycontinuous through the distal portion of the retrieval bag 20.

With reference to FIGS. 7-9, an embodiment of tissue retrieval bag 20′is illustrated combining several aspects of tissue retrieval bagsdiscussed herein. FIG. 7 illustrates the tissue retrieval bag 20′ in apartially formed state illustrating partial assembly of the bag from aflat sheet of a film before a closed end of the bag has been formed suchas by welding. FIG. 8 illustrates the tissue retrieval bag 20′ in anassembled state with a sealed closed end. In the illustrated embodiment,the tissue retrieval bag 20′ includes a distal end that has beenreinforced with a reinforcing section 60 joined to the remainder of thebag 20′ at a seam 62. For example, in one embodiment, the retrieval bag20′ can comprise a 4 mil film, and the reinforcing section can comprise,for example, a second layer of film material having a thickness of 2 milfor a total 6 mil thickness at the reinforcing section. As discussed infurther detail with respect to FIGS. 10-13, the seam 62 can include aspace or gap 64 therein to provide a vented cavity between thereinforcing section 60 and ambient conditions.

With continued reference to FIGS. 7-9, In the illustrated embodiment,the cord loop 32 passes through a cuff 30 at an opening 36 in the cuff32. The cuff 30 can be formed in a flat sheet of film material byfolding a portion of the film material over itself and joining thefolded portion to the remainder of the material such as by welding.Desirably, the cuff 30 can be formed with the cord loop 32 in place. Inthe illustrated embodiment, the cuff is substantially continuous, as itincludes a plurality of reinforcing tabs 38 joined to the cuff 30 toprovide enhanced strength for a portion of the cuff encountering arelatively high tensile stress during use. Desirably, at least onereinforcing tab 38 can be added to the cuff 30 to form a reinforcedsection of the cuff 30. In the illustrated embodiment, two reinforcingtabs 38 are joined to the cuff 30 to reinforced the distal-most end ofthe cuff. In other embodiments, more or fewer than 2 reinforcing tabscan be added to the cuff to form a cuff having the desired level ofcontinuity and reinforcement.

A detail view of one reinforcing tab 38 is illustrated in FIG. 9. In theembodiment illustrated in FIG. 9, the reinforcing tab 38 is formed froma segment of a film material having a substantially hourglass shape.Advantageously, such a geometry can facilitate folding and rolling ofthe tissue retrieval bag 20′ to a relatively low diameter configurationfor installation in a trocar. In other embodiments the cuff tab can havedifferent geometries, such as substantially rectangular or ovalgeometries to create a cuff having desired strength and stowageproperties.

Certain aspects of the retrieval bag described herein for use with 5-7mm trocars can also be adapted to be used with 10 mm and larger diametertrocars. In this case, the diameter of the introducer tube would beapproximately 10 mm, such as, for example, 10-12 mm. For example, atissue retrieval system with an approximately 10 mm introducer tube caninclude a tissue retrieval bag having elongate profile comprising a filmthickness of approximately 8 mils. Advantageously, such a tissueretrieval bag with an elongate profile has enhanced tensile and burststrength characteristics as compared to prior 10 mm retrieval bags.

In other embodiments of tissue retrieval system for use with 10 mm andlarger diameter trocars, a tissue retrieval bag can be configured tohave a relatively large volume, rather than enhanced strength ascompared to prior 10 mm retrieval bags. For example, in someembodiments, an elongate profile of a tissue retrieval bag configuredfor use with 5-7 mm trocars can be generally scaled up in size, but notfilm thickness, to be used with 10 mm and larger diameter trocars. Thus,the resulting tissue retrieval bag would fit within a 10 mm introducertube and have an increased volume relative to prior 10 mm tissueretrieval bags to accommodate a large tissue specimen, such as a spleen.In other embodiments, the dimensions and film thickness of a tissueretrieval bag for use with a 10 mm or larger diameter trocar can each beselected such that the tissue retrieval bag has desired volume andstrength characteristics.

In some embodiments, the tissue retrieval system can be provided with a15 mm introducer tube and incorporate a larger version of a tissueretrieval bag having the elongate profile of the 5 mm retrieval bagdescribed above. In some embodiments, the 15 mm retrieval bag could alsoincorporate film materials with greater thicknesses than those utilizedfor the 5 mm retrieval bags, or some combination of an elongate profileand varied film thickness.

With reference to FIGS. 2, 5, and 6, in some embodiments, the tissueretrieval systems 10 described herein include retrieval bag support arms40 which are biased to a predetermined position when the tissueretrieval system is in the deployed configuration. For example, in theillustrated embodiment, the support arms 40 are biased to springradially outward and transversely upward with respect to a longitudinalaxis defined by the introducer 3 upon deployment of the retrieval bag 20from the introducer 3. Desirably, by springing transversely upward upondeployment of the retrieval bag 20, the support arms create an accessposition having an angled entry for the rim 26 of the retrieval bag 20relative to the axis of the introducer 3. Advantageously, the angledentry facilitates the loading of tissue specimens during laparoscopicprocedures as it allows a grasped tissue sample to be easily disposedwithin the retrieval bag 20. This ease of loading can be particularlyadvantageous for single incision laparoscopic procedures where thegrasped tissue is held by a grasper that is disposed through the sameincision as the retrieval system introducer 3. Thus, the transverseorientation of the retrieval bag 20 rim 26 relative to the longitudinalaxis of the introducer 3 enables a tissue specimen held by a grasper tobe easily inserted and pushed towards the distal end 24 of the retrievalbag 20 during single incision laparoscopic procedures where it wouldotherwise be particularly difficult to create a substantial axial anglebetween the grasper shaft and the introducer tube.

With continued reference to FIGS. 2, 5, and 6, in some embodiments, atissue retrieval system can include support arms 40 designed to flexopen and upward upon deployment of the retrieval bag 20 from within theintroducer 3 tube to facilitate the loading of a tissue specimen sampleduring standard laparoscopic procedures and during single incisionlaparoscopic procedures. As illustrated, the support arms 40 can be bentto include upward bends 42 in each support arm 40 in the sections of thesupport arms that are proximal to where a bead 50 is positioned anddistal to the end of the actuation rod. When viewed from a topperspective, as illustrated in FIG. 6, each of the support arms 40 canalso include a radial bend, curve, or curved profile 44. As theretrieval bag 20 is advanced out of the introducer 3, the support arms40 spring radially outward to return to the radial curved profile 44,thus opening the retrieval bag. As the retrieval bag 20 is furtheradvanced out of the introducer 3, the support arms 40 spring upwardabout the bends 42 in the support arms 40 to position the retrieval bag20 in the access position with an angled opening relative to thelongitudinal axis of the introducer 3. As the retrieval bag 20 iscinched closed, the support arms 40 flex downward and radially inward asthey are retracted into the introducer 3.

In some embodiments, the support arms 40 can be formed from 17-7 PHstainless steel, which is a typical spring metal. In other embodiments,the support arms 40 can comprise other metals and metal alloys havingdesired biasing properties. In other embodiments, the support arms 40can be formed of a memory metal such as a nickel titanium alloy ornitinol metal. The memory metal can be preshaped to be generally linearin the introducer 3 with the tissue retrieval system in the initialconfiguration and to form a radially expanded and transversely bentshape upon application of body heat to the support arm 40 as the tissueretrieval bag 20 is deployed into a body cavity.

Instead of, or in addition to the biased support arms 40 discussedabove, in some embodiments, the support arms can pivot about a pin andthe tissue retrieval system can include a torsion spring to drive thesupport arms upward upon deployment from the introducer tube. Thisspring-biased pivot mechanism can provide the retrieval bag with anangled opening relative to the longitudinal axis of the introducer tube.

During clinical use of the tissue retrieval systems described herein, anaccess device such as a trocar is first placed through a body wallleaving the trocar cannula disposed across the body wall. In someembodiments, it is contemplated that a would retractor, such as anAlexis® would retractor can be positioned in an incision in thepatient's body before placement of the trocar cannula. In theseembodiments, a wound retractor is initially inserted into an incision.Then, any adjustments to the length or diameter of the wound retractorare made. For example, with certain wound retractors, an external ringof the retractor can be rolled to remove slack in an elastomeric sheetforming the wound retraction surface.

The tissue retrieval system 10 is then inserted into the trocar seal andcannula until the distal end of the introducer 3 extends beyond thedistal end of the trocar cannula. The retrieval bag 20 is then deployedfrom within the introducer 3 and into the body cavity by pushing theactuator 7 in a distal direction relative to the introducer 3. In someembodiments of tissue retrieval system, the actuator rod can include aratcheting mechanism which allows distal movement of the actuator 7during retrieval bag deployment and prevents the actuator 7 from beingpulled in a proximal direction to ensure proper operation of the device.Once extended into the body cavity, the retrieval bag 20 is suspendedand held open by two support arms 40 that extend into the cuff 30 on theretrieval bag 20.

The retrieval bag 20 can include an integral bead 50 through which thesupport arms 40 can slide. The retrieval bag 20 also includes a cordloop 32 which runs through the cuff 30 of the retrieval bag 20 and isreleasably attached to the actuator 7. In some embodiments, the bead 50includes a frictional lock through which the cord loop 32 runs to enablethe retrieval bag 20 to be cinched closed and reopened as needed.Various aspects of an introducer and guide bead that can be used inconjunction with the various retrieval bags 20, 20′, 20″ describedherein are further described in U.S. patent application Ser. No.11/549,971 entitled “TISSUE RETRIEVAL SYSTEM,” filed on Oct. 16, 2006,currently pending, which is incorporated herein by reference in itsentirety.

With reference to FIG. 4A, an some embodiments, the bead 50 can includean expandable, relatively large diameter member such as a snap ring 52positioned about a periphery thereof. In the illustrated embodiment, thesnap ring 52 can prevent reentry of the guide bead 50 into theintroducer 3 once the actuator 7 has advanced the retrieval bag 20 andguide bead 50 out of the introducer, thus facilitating cinching of theretrieval bag 20 when the cord 32 is pulled. In other embodiments aportion of bag material adjacent the guide bead 50 can facilitatecinching of the retrieval bag 20. For example, in these embodiments, theguide bead 50 can be pulled within the introducer 3 tube while thetissue retrieval bag 20 can collect and bunch up outside the introducer3 tube when the cord is pulled.

With reference to FIGS. 4B, 4C, and 4D, in some embodiments, introducer3 can have a distal end configured to allow passage of the guide bead 50during deployment of the retrieval bag 20 while also restricting reentryof the deployed guide bead 50 into the introducer 3. In the illustratedembodiment, the distal end of the introducer 3′ can comprise at leastone restrictor such as one or more generally vee-shaped ramped surfaces13. In the illustrated embodiment, the introducer 3′ includes twogenerally diametrically opposed ramped surfaces 13. In certain otherembodiments, the introducer 3′ can have more or fewer than two rampedsurfaces, and the ramped surfaces can be generally regularly spacedabout the periphery, or can be irregularly spaced. The ramped surfacescan define a gradually decreasing inner diameter of the introducer 3′ toa relatively low diameter region 15 minimum inner diameter at the distalend. Desirably, the ramped surfaces 13 extend a relatively shortdistance in a longitudinal direction such that the ramped surfaces 13 donot interfere with movement of the actuator 7. In some embodiments, theguide bead 50 can include an interface surface, such as a diametric step54 to interface with ramped surfaces 13 of the introducer 7.Advantageously, in the illustrated embodiment, the ramped surfaces 13facilitate easier passage of the rolled retrieval bag 20 through theintroducer 3′ while preventing reentry of the guide bead 50 to cinch theretrieval bag 20.

Once a tissue specimen such as a gallbladder is separated from theadjoining vessels and structures, it can then be placed into theretrieval bag 20. The actuator 7 is then pulled proximally to withdrawthe support arms 40 from the cuff 30 and the bead 50 on the retrievalbag 20. The actuator 7 can include a ratcheting mechanism which allowsproximal movement of the actuator 7 during cinching of the retrieval bag20 and prevents distal movement of the actuator 7 to ensure proper andcomplete closure of the retrieval bag 20. As the support arms 40 arepulled out of the cuff 30 of the retrieval bag 20 and through the bead50, tension is then applied to the cord loop 32 to cinch the bag 20closed. Once the retrieval bag 20 is fully closed, a small loop of thecord 32 is exposed on the actuator 7 near the proximal end of theintroducer 3.

At this stage, there are at least three methods for withdrawal of theretrieval bag 20 from within the body cavity. For one method, theretrieval bag 20 can be completely detached and removed from theactuator 7 and introducer 3 by lifting the cord loop 32 from a retainingfeature such as a retaining slot on the actuator 7. The device and thetrocar seal and cannula can then be withdrawn from the body wall leavingthe retrieval bag 20 in the body cavity and the cord loop 32 disposedacross the body wall. The neck of the retrieval bag 20 can then bewithdrawn through the body wall using the bead 50 as a dilator to aidwith movement of the retrieval bag through the layers of tissue fibersin the body wall. Once the neck of the retrieval bag 20 has traversedthe body wall, the retrieval bag can then be reopened by manuallygrasping the closed end of the retrieval bag 20 and the bead and slidingthe bead 50 along the cord 32. The retrieval bag 20 can then be accessedto remove or compact its contents to aid with complete withdrawal fromthe body cavity using standard open and endoscopic instrumentation suchas forceps, graspers, and aspiration probes. Once the bulk of thecontents are removed, the retrieval bag 20 can then be closed bymanually grasping the open end of the retrieval bag 20 and the bead andsliding the bead 50 along the cord 32. The cord loop 32 can then begrasped manually and the retrieval bag 20 then completely withdrawn fromthe body cavity.

A second method for withdrawal of the retrieval bag 20 from within thebody cavity can be used for small tissue specimens placed in theretrieval bag 20 which are not likely to need to be aspirated,compacted, or removed from the retrieval bag 20 prior to withdrawal ofthe retrieval bag 20 through the body wall. In this case, the cord loop32 can be left attached to the actuator 7 and the entire device alongwith the trocar seal and cannula can be simultaneously withdrawn fromthe body cavity and through the body wall.

In a third method, the tissue retrieval systems described herein can beused in conjunction with a wound retractor such as an Alexis® retractor,as discussed above. A method of using a tissue retrieval system inconjunction with a wound retractor includes first inserting a smallwound retractor in the wound that would be lightly tensioned such as byinverting an external ring of the wound retractor to remove slack in thewound retractor sleeve. A trocar is then inserted within the sleeve ofthe wound retractor into the lined incision. A tissue retrieval system,such as one of the embodiments discussed herein would be insertedthrough the trocar and deployed. A tissue specimen is placed in thedeployed bag. Once the specimen is placed in the tissue bag, the bag iscinched closed. In certain embodiments described herein, the cord loopcan be detached from the actuator. With the bag cinched closed about aspecimen contained therein, the introducer tube can be removed from thebag. In some embodiments, the trocar can also removed from the surgicalsite. The wound retractor is then fully tensioned to retract the woundto facilitate removal of the tissue bag from the body cavity such as byinverting an external ring to fully retract the incision site. With theincision site fully retracted, the retrieval bag described herein can bepulled through the wound retractor and out of the patient.Advantageously, a wound retractor can allow a tissue retrieval bag to bepulled through a relatively small incision without requiring theincision to be extended for passage of the bag therethrough.

The tissue retrieval bags 20 described herein can be utilized as standalone retrieval bags that would be delivered to the surgical sitethrough a trocar by rolling the retrieval bags and then pushing orpulling them through a trocar. A retrieval bag 20, in this aspect, wouldbe provided with a cord loop 32 and can also be provided with a guidebead 50 or alternatively a slip knot for cinching the bag 20 closed. Thereinforced distal section of the rim 26 of the retrieval bag 20 canallow the distal portion of the retrieval bag cuff 30 to remain in anopen position without the need for metal or plastic supports. Thisversion of the retrieval bag can be delivered through various trocarsranging in diameter from 5-15 mm. The stand-alone retrieval bag 20 couldbe formed from thick laminate materials to enable the use of tissuemorcellators to be utilized for reducing the size of large tissuespecimens such as the spleen. The elongate profile of the retrieval bag20 facilitates the insertion and use of a tissue morcellator within theretrieval bag and is particularly advantageous during single incisionlaparoscopic procedures. The elongate profile retrieval bag also enablesthe retrieval bag 20 to be delivered to and fit within confined surgicalsites due to its low profile shape.

With reference to FIGS. 10-15, various embodiments of hybrid tissueretrieval bags 20″ are illustrated. Rather than being formed ofmaterials having substantially uniform properties extending along theretrieval bag between an open end and a closed end, in variousembodiments, the hybrid specimen retrieval bags have at least twoportions with different properties (such as, for example, compliance,thickness, or number of layers of material), such that the bags areadapted for the clinical environment in which they are deployed. Asdiscussed above with reference to FIGS. 7-8, in some embodiments, ahybrid tissue retrieval bag 20′ can have an elongate profile. In otherembodiments, as illustrated in FIGS. 10-15, a hybrid tissue retrievalbag can have a profile that extends generally perpendicularly to alongitudinal axis of the introducer tube 3 between an open end and aclosed end of the bag.

Tissue retrieval bags formed of a material with uniform propertiesthroughout can create undesirable stress concentrations in use.Retrieval bags typically have a large diameter opening in the cuffportion to facilitate insertion of a specimen and a smaller diameter ofthe distal closed-end of the retrieval bag. An exemplary uniform tissueretrieval bag with an internal diameter of about 2.75″ and a wallthickness of about 4 mil in the cuff portion of the bag will experiencea tensile stress of about 867 PSI in the cuff portion of the bag undertensile load of about 30 pounds. The same retrieval bag with an internaldiameter of about 0.75″ and a wall thickness of about 4 mil at thedistal end of the bag will experience a stress of about 3166 PSI in thedistal end of the bag under the same tensile load of about 30 pounds.The induced tensile stresses of the uniform-material retrieval bag inthe cuff portion and the lower distal portions are not balanced due tothe differences in their respective diameters. The induced tensilestress of 867 PSI in the cuff portion of the bag is relatively lowcompared to the induced tensile stress of 3166 PSI in the distal end ofthe bag. Thus, a substantially uniform non-hybrid bag can require arelatively high strength material or a relatively thick materialthroughout to provide a desired strength at the distal end even whensuch a material is not required at the cuff portion of the bag.Accordingly, it can be desirable that a specimen retrieval bag beconfigured to generate a more balanced stress response under tensileloads expected in clinical application.

Thus, advantageously, in some embodiments, the tissue retrieval systemcan include a retrieval bag configured to provide enhanced strength atstress concentrations versus prior art retrieval bags. In someembodiments, the tissue retrieval system can include a “hybrid”retrieval bag 20″ configured to provide localized areas of relativelyhigh strength and localized areas of relatively lower strength andhigher compliance. The hybrid retrieval bag can have localized areas ofhigh strength in locations such as a distal, closed end and/or a distalend of the cuff, where tissue retrieval bags typically encounterrelatively high stress. FIG. 10 illustrates an exemplary hybrid tissueretrieval bag 20″ in a tissue retrieval system 10′ including a handle 9,an actuator rod 7, and an introducer tube 3 for insertion through atrocar.

With reference to FIG. 11, in some embodiments, a hybrid retrieval bag20″ can be formed of at least two different film materials to providerelatively high flexibility at the proximal open end of the retrievalbag 20″ and relatively high strength at the distal closed-end of theretrieval bag 20″. With reference to FIG. 12, in other embodiments, ahybrid retrieval bag 20″ can be formed with at least two differentthicknesses of the same film material. In some of these embodiments, theretrieval bag 20″ can be formed with a relatively thin film in theproximal open end of the retrieval bag 20″ to enhance flexibility whilemaintaining adequate strength and a relatively thick film in the distalclosed-end of the retrieval bag 20″ to enhance strength while enablingthe retrieval bag 20″ to be rolled and stored in the introducer tube 3.

In other embodiments, a hybrid retrieval bag 20″ can be formed with atleast two different thicknesses of at least two different filmmaterials. In certain of these embodiments, the hybrid retrieval bag 20″can provide flexibility at the open proximal end of the retrieval bag20″ and strength at the distal closed-end of the retrieval bag 20″ whileenabling the retrieval bag 20″ to be easily rolled and stored in theintroducer tube 3.

With reference to FIGS. 14-15, in some embodiments, a hybrid retrievalbag 20″ can be formed with one or more compliant features such as holesor slots in the cuff portion of the bag to provide the cuff with anincreased degree of compliance. In these embodiments, a relatively stiffhigh-strength material can be used for forming the tissue retrieval bag20″.

One embodiment of hybrid retrieval bag 20″ formed of two film materialsis illustrated in FIG. 11. In the illustrated embodiment, the hybridretrieval bag 20″ formed from two film materials is advantageous in thata first film material with a relatively high elongation and low moduluscan be used for the upper cuff portion 158 of the retrieval bag 20″ anda second film material with a relatively low elongation and a highmodulus can be used for the lower, distal end portion 160 of theretrieval bag 20″. A high modulus material requires a greater amount offorce or pressure to be applied to the material to produce a givenamount of elongation as compared to a low modulus material. Thus,advantageously, in the illustrated embodiment, the tissue retrieval bag20″ will have relatively low elongation at the distal end portion 160,which, as discussed above, encounters relatively high tensile stressduring clinical use.

By using a relatively high modulus film for the lower distal end portion160 of the retrieval bag, the retrieval bag 20″ will have a greaterresistance to localized deformation and elongation than a comparablenon-hybrid tissue retrieval bag. Thus, the hybrid configuration of theretrieval bag 20″ contributes to the ability of the retrieval bag with acontained specimen to be easily withdrawn through the abdominal wall ofthe patient. The high modulus film material will not elongate as much asa low modulus film material and will therefore be less susceptible todeformation under the high tensile force that can be applied to theretrieval bag during withdrawal of the retrieval bag from thatperitoneal cavity. Under the high tensile forces applied to theretrieval bag during withdrawal from the peritoneal cavity, a non-hybridretrieval bag formed solely of low modulus film materials cansignificantly elongate and stretch until the retrieval bag deforms totake on a bulbous shape within the peritoneal cavity. Once a retrievalbag deforms to a bulbous shape, it can be difficult to remove theretrieval bag through the abdominal wall. In certain instances where aretrieval bag formed of a low modulus film has deformed, it can berequired that the abdominal wall tract is enlarged to enable passage ofthe retrieval bag through the tract. In some cases, aspiration of someof the retrieval bag contents must be conducted with anirrigation/aspiration probe to enable passage of the retrieval bagthrough the abdominal wall tract.

Advantageously, a hybrid retrieval bag formed of a high modulus filmmaterial for the lower portion 160 of the retrieval bag 20″ is lesslikely to deform than a comparable non-hybrid retrieval bag formed of arelatively low-modulus material. Furthermore, the hybrid retrieval bag20″ tends to force the contained specimen to elongate within theretrieval bag 20″ and to conform to the shape of the retrieval bag 20″and thus facilitates withdrawal of the retrieval bag from the peritonealcavity.

With continued reference to FIG. 11, one embodiment of retrieval bag 20″formed from two film materials includes an upper cuff portion 158 formedof a first film material and a lower, distal end portion 160 formed of asecond film material having a different compliance and a differentmodulus than the first film material. In the illustrated embodiment, theupper cuff portion 158 has a depth toward the closed end of the bag thatmeasures about 1.5″ from the open end of the retrieval bag 20″. In otherembodiments, the upper cuff portion 158 can have different depths. Forexample in some embodiments, the upper cuff portion can have a depthwithin the range of about one half an inch to about three inches, inother embodiments, the upper cuff portion can have a depth between aboutone inch and about two and a half inches, and in other embodiments, theupper cuff can have a depth of between about one and a quarter inchesand one and three quarters inches.

In various embodiments, tissue retrieval bags discussed herein can besized for different tissue removal applications. For example, in theillustrated embodiment, the retrieval bag 20″ can have a total depthbetween the open end and the closed end of approximately 5 inches, butin other embodiments, it can be desirable to have a retrieval bag with atotal depth of less than 5 inches or greater than 5 inches. Accordingly,to account for dimensional differences in different sized bags, it canbe useful to describe the depth of the upper cuff portion 158 in termsof a ratio with the total depth of the tissue retrieval bag 20″. In someembodiments, the ratio of the depth of the upper cuff portion to thedepth of the bag from the open end to the closed end is between about1:10 and about 1:1.5, in other embodiments, the ratio of the depth ofthe upper cuff of the tissue retrieval bag to the total depth of the begis between about 1:4 and about 1:1.8, and in other embodiments, theratio of the depth of the upper cuff of the retrieval bag to the totaldepth of the tissue retrieval bag is between about 1:3 and about 1:2.

In the illustrated embodiment, the first film material, comprising theupper cuff portion 158 comprises a 0.004″ or 4 mil polyurethane filmmaterial, although in different embodiments, different thicknesses offilm can be used, such as, for example, a 2 mil film, 6 mil film, orfilm of another suitable thickness. Furthermore, while in theillustrated embodiment, the upper cuff portion 158 comprises apolyurethane material, in other embodiments, the first film material cancomprise another suitable film material.

Film material properties are typically reported as modulus at 100%elongation of the film with modulus in the units of pounds per squareinch or pascals. As illustrated, the first film material comprising theupper cuff portion 158 has a modulus of about 950 PSI at 100%elongation. In other embodiments, the modulus can be between about 500PSI at 100% elongation and about 1300 PSI at 100% elongation. In stillother embodiments, the modulus can be between about 750 PSI at 100%elongation and about 1100 PSI at 100% elongation. In other embodiments,the modulus can be between about 900 PSI at 100% elongation and about1000 PSI at 100% elongation.

With continued reference to FIG. 11, the lower, distal or closed-endportion 160 of the retrieval bag 20″ is formed of a second film materialhaving a second compliance or modulus. As illustrated, the distal-endportion 160 of the retrieval bag 20″ has a depth measuring about 3.5″from the interface or joint 162 with the upper cuff portion 158 of theretrieval bag to the closed end of the bag 20″. In other embodiments,the distal-end portion of the bag can have a depth of between about 1inch to about 4½ inches, in other embodiments, the distal end portion ofthe bag 20″ can have a depth between about 2½ inches and about 4 inches,and in other embodiments, the distal end portion of the bag can have adepth between about 3¼ inches and about 3¾ inches.

In terms of a ratio of depth of the distal end portion 160 of the bag20″ to the total depth of the bag 20″ between the open end and theclosed end, in some embodiments, the ratio of the depth of the lowerportion of the bag 20″ to the total depth is between about 1:3 and about1:1.1, in other embodiments, the ratio of the depth of the distal-endportion of the tissue retrieval bag to the total depth of the beg isbetween about 1:2.2 and about 1:1.3, and in other embodiments, the ratioof the depth of the distal-end portion of the retrieval bag to the totaldepth of the tissue retrieval bag is between about 1:2 and about 1:1.5.

In the illustrated embodiment, the second film material comprises a0.004″ or 4 mil polyurethane film material, although in differentembodiments, different thicknesses of film can be used, such as, forexample, 2 mil film, 6 mil film, or film of another suitable thickness.Furthermore, in other embodiments, the second film material can compriseanother suitable film material.

As illustrated, the second film material comprising the distal endportion 160 of the retrieval bag 20″ has a modulus of about 1600 PSI at100% elongation. In other embodiments, the modulus can be different,although always relatively high when compared to the modulus of firstfilm material for the cuff portion 158 in the corresponding embodiment.For example, in other embodiments, the modulus of the second filmmaterial can be between about 1000 PSI at 100% elongation and about 2200PSI at 100% elongation. In still other embodiments, the modulus can bebetween about 1200 PSI at 100% elongation and about 2000 PSI at 100%elongation. In other embodiments, the modulus can be between about 1500PSI at 100% elongation and about 1700 PSI at 100% elongation.

The relatively low modulus material in the cuff portion 158 of theretrieval bag 20″ can allow the bag 20″ to be easily opened and closedwhile the relatively high modulus material in the lower distal-endportion 160 of the retrieval bag 20″ can reduce or substantially preventelongation of the retrieval bag and force the specimen itself to take onthe shape of the retrieval bag. Thus, the described hybrid retrieval bag20″ can provide eased withdrawal of the retrieval bag from the bodycavity as compared to a comparable non-hybrid bag.

With reference to FIG. 12, other embodiments of hybrid retrieval bag 20″are illustrated including at least two portions having film material ofdifferent thicknesses. A retrieval bag 20″ formed with two differentthicknesses of film material can be advantageous in that the cuffportion 158′ of the retrieval bag 20″ can be formed of a smaller gaugefilm than in a distal-end portion 160′ of the retrieval bag 20″. Thus,the cuff portion 158′ of the retrieval bag is relatively compliantcompared to the distal-end portion 160′. The strength and punctureresistance of the distal-end portion 160′ of the retrieval bag 20″ canbe enhanced by utilizing a relatively larger gauge film. A larger gaugefilm can be used in the distal-end portion 160′ of the retrieval bagthan would otherwise be possible if the retrieval bag with the sameshape and size were to be manufactured entirely from a uniform thicknessfilm. By incorporating a relatively thin film in the cuff portion 158′of the retrieval bag and a relatively thick film in the distal-endportion 160′ of the retrieval bag 20″, the volume of the bag when rolledand stored in the introducer tube 3 can be substantially equivalent tothe volume of retrieval bag formed with a uniform film thickness. But,the hybrid retrieval bag 20″ can have a significantly greater strengthin the distal-end portion 160′ of the retrieval bag (where strength canbe highly desirable) than a comparable non-hybrid uniform film thicknessbag.

In the illustrated embodiment, the distal-end portion 160′ of theretrieval bag 20″ has a circumference which is significantly less than acircumference of the cuff portion 150′ of the retrieval bag. Asdiscussed above, for a retrieval bag formed from a uniform thicknessfilm, the stress transferred to the cuff portion of the retrieval bagduring withdrawal of the bag from a patient by cinching the cord loop132 through the cuff 130 is significantly less than the stresstransferred to the lower distal portion of the tissue bag. Thus, a thingauge film can be used in the cuff portion 158′ of the retrieval bag toprovide a desired tensile strength while a thick gauge film can be usedin the distal-end portion 160′ of the retrieval bag 20″ to provideincreased tensile strength, increased hoop strength, and increasedpuncture resistance. In various embodiments, these improvements can beobtained in hybrid tissue retrieval bags 20″ using two thicknesses ofthe same film material or two thicknesses of different film materials.

With continued reference to FIG. 12, one exemplary embodiment of ahybrid retrieval bag 20″ can have a cuff portion 158′ with an internaldiameter of about 2.75″ and a wall thickness of about 2 mil in the cuffportion. Accordingly, the cuff portion 158′ of the illustratedembodiment of retrieval bag 20″ will experience a tensile stress ofabout 1735 PSI under a tensile load of about 30 pounds.

In the illustrated embodiment, the same retrieval bag 20″ can have aninternal diameter of about 0.75″ and a wall thickness of about 6 mil atthe distal end of the bag. Accordingly, the distal end portion of theillustrated embodiment of retrieval bag will experience a tensile stressof about 2105 PSI under a tensile load of about 30 pounds. Thus,advantageously, the tensile stresses encountered by the illustratedtissue retrieval bag 20″ are substantially more balanced as comparedwith the exemplary comparable uniform, non-hybrid tissue retrieval bagdescribed above.

With continued reference to FIG. 12, while the illustrated embodiment ofretrieval bag 20″ includes a cuff portion 158′ having a 2 mil filmthickness and a distal end portion 160′ having a 6 mil film thickness,it is contemplated that in other embodiments, other film thicknesses canbe used. For example, in some embodiments, the cuff portion can have afilm thickness of between about 1 mil and about 5 mil, in otherembodiments, the cuff portion can have a film thickness of between about2 mil and about 4 mil. In some embodiments, the distal portion can havea film thickness greater than that of the cuff portion of thecorresponding embodiment and between about 3 mil and about 9 mil, inother embodiments, the distal portion can have a film thickness greaterthan that of the cuff portion of the corresponding embodiment andbetween about 5 mil and 7 mil.

Advantageously, a hybrid retrieval bag 20″ with varying wallthicknesses, can have substantially balanced stresses between the cuffportion 158′ and the distal-end portion 160′. Thus, a hybrid retrievalbag can be configured to provide a desired strength at the distal endwhile maintaining compliance at the cuff for installation in an insertertube. In some embodiments, the material thicknesses of the cuff portionand distal portion of the hybrid retrieval bag can be chosen such thatfor a predetermined tensile load, the corresponding tensile stresses areequal.

With reference to FIG. 13, in some embodiments of hybrid tissueretrieval bag 20″, the retrieval bag 20″ can be formed with a reinforcedwall segment in the distal-end portion 160″ of the bag. As discussedabove, during withdrawal of the retrieval bag 20″ through a body wall,the specimen is typically forced into the distal-end portion 160″ of thebag, subjecting this portion of the retrieval bag to high stresses. Thedistal portion of the retrieval bag typically has the leastcross-sectional area for supporting a tensile load and it is thereforeadvantageous to enhance the strength of the distal portion of theretrieval bag. Thus, in some embodiments, it can be advantageous toincrease the strength of the distal-end portion 160″ of the retrievalbag by providing a reinforced section, such as a multiple layer wallsection. In the illustrated embodiment, the reinforced section comprisesa double wall configuration in the distal-end portion 160″ of theretrieval bag 20″. Advantageously, by providing a reinforced section inonly the distal-end portion 160″ of the retrieval bag 20″, the tensilestrength of the distal-end portion 160″ of the bag 20″ can be relativelyincreased while maintaining the rolled volume of the retrieval bag 20″at a relatively small diameter compared to a non-hybrid retrieval baghaving equivalent tensile strength at the distal end. Thus, the hybridretrieval bag 20″ can be rolled and stored in a relatively low-diameterintroducer tube 3 as compared to a non-hybrid retrieval bag havingequivalent tensile strength at the distal end.

In some embodiments, the reinforced section of the hybrid retrieval bag20″ comprises at least two layers of the same film material. In otherembodiments, the reinforced section comprises at least two layers ofdifferent film materials. Moreover, in some embodiments, the reinforcedsection is formed with at least two layers of the same film materialeach having different thicknesses. In other embodiments, the reinforcedsection is formed of at least two layers of different film materialseach having different thicknesses. In still other embodiments, thereinforced section is formed of at least two layers of film materialhaving a substantially identical thickness.

In some embodiments, the hybrid retrieval bag 20″ with a reinforcedsection can be reinforced with a very stiff high modulus, high-strengthmaterial that might not otherwise be suitable on its own formanufacturing a retrieval bag. For example in one embodiment, aretrieval bag formed of a polyurethane film can be reinforced with afabric material such as a non-coated rip stop nylon to prevent thedistal portion of the retrieval bag from deforming during withdrawalfrom a body cavity.

In certain embodiments, the reinforced section of the distal-end portion160″ can be coupled to the hybrid retrieval bag 20″ in various ways. Forexample, in various embodiments, the reinforced section can bechemically adhered to the retrieval bag with a bio-compatible chemicaladhesive. In other embodiments, the reinforced section can be thermallyfused to the tissue retrieval bag. In other embodiments, the reinforcedsection can be ultrasonically welded to the retrieval bag. In someembodiments, the reinforced section can be overmolded or dip molded ontothe retrieval bag. In some embodiments, the reinforced section can besewn onto the retrieval bag. The hybrid specimen retrieval bags 20″illustrated in FIGS. 11-12 can be formed with similar processes forjoining the cuff portions 158, 158′ to the distal-end portions 160,160′, as discussed with respect to the specimen retrieval bags 20″ ofFIG. 13, and can each include a joint 162, 162′ between thecorresponding cuff portions 158, 158′ and distal-end portions 160, 160′.

With continued reference to FIG. 13, in some embodiments a hybridretrieval bag 20″ with a reinforced section can have an external joint162″ such as a weld or seam extending along an outer surface of thetissue retrieval bag between the reinforced section of the distal-endportion 160″ and the cuff portion 158″ of the tissue retrieval bag 20″.In other embodiments, the reinforced section of the distal-end portion160″ can be disposed on an interior surface of the retrieval bag 20″such that an internal joint such as a weld or seam extends along theinner surface of the tissue retrieval bag.

In some embodiments, the reinforced section is coupled to the distalportion of the retrieval bag 20″ over substantially an entire innersurface of the reinforced section. For example, in some embodiments, thereinforced section 20″ can comprise a laminate of two layers of filmmaterial. In other embodiments, the reinforced section is coupled to thedistal-end portion 160″ of the retrieval bag 20″ over a portion of theinner surface of the reinforced section such that one or more gaps orcavities is formed between the reinforced section and the retrieval bag.For example, in some embodiments, the reinforced section can be coupledto the retrieval bag 20″ at a substantially curvilinear joint, seam, orweld at a proximal end of the reinforced section while a cavity isformed between the retrieval bag and substantially all of the reinforcedsection distal of the joint, seam, or weld. In other embodiments, aportion of the joint, seal, or weld can extend distally from theproximal end of the reinforced section towards the distal, closed end ofthe retrieval bag such that more than one gap or cavity is createdbetween the reinforced section and the retrieval bag 20″.

In embodiments of tissue retrieval bag 20″ having at least one gap orcavity between the reinforced section and the retrieval bag, the tissueretrieval system can include a vent fluidly coupling the at least onegap or cavity to ambient conditions exterior to the tissue retrievalsystem or to the interior of the tissue retrieval bag. Thus, in ventedembodiments of tissue retrieval system, a volume of gas in the gap orcavity of the tissue retrieval system would not restrict the assembly,foldability or rollability of the tissue retrieval system due toconsequent compression of the volume of gas within the gap or cavity. Insome embodiments, the vent can comprise one or more unjoined segmentsalong the joint such as intermittent weld or small breaks in the weld ofa welded seam (as illustrated, for example, in the gap 64 in seam 62 ofthe retrieval bag 20′ illustrated in FIG. 7). In other embodiments, thejoint can be substantially contiguous, and the vent can comprise one ormore holes in the reinforced section fluidly coupling the gap or cavityto ambient conditions, or one or more holes in the tissue retrieval bagunder the reinforced section.

As discussed above, a comparable non-hybrid retrieval bag with aninternal distal diameter of about 0.75″ and a wall thickness of about 4mil at the distal end of the bag will experience a tensile stress ofabout 3166 PSI under a tensile load of about 30 pounds. With continuedreference to FIG. 13, an exemplary embodiment of hybrid retrieval bagcomprises a 4 mil material with a reinforced section of an additional 4mil film layer at the distal portion. In the illustrated embodiment, thetissue retrieval bag can have an internal diameter of about 0.75″ and awall thickness of about 8 mil (comprised of two 4 mil layers), at thedistal end portion 160″ of the bag. The illustrated hybrid specimenretrieval bag 20″ will experience a tensile stress of about 1575 PSI atthe distal-end portion 160″ under a tensile load of about 30 pounds.Thus, advantageously, by providing a retrieval bag with a reinforcedsection having a double-layer wall at the distal-end portion 160″ of theretrieval bag 20″, the overall strength of the retrieval bag 20″ can besignificantly increased.

With reference to FIGS. 14-15, in some embodiments of hybrid tissueretrieval bag, the tissue retrieval bag 20″ can have a compliant cuff130′, 130″ through which a cord loop 132 passes and a bag portion 180extending from the cuff 130′, 130″ to the closed end of the bag 20″. Thecuff 130′, 130″ can be relatively compliant relative to the bag portion180. In some embodiments, the bag portion 180 can comprise an upper bagportion and a lower bag portion, each having different properties (forexample, the bag portion 180 can be similar to the upper cuff portionand lower distal end portion of one of the hybrid retrieval bagsdescribed with respect to FIGS. 11-13 with the compliant cuff 130′, 130″desirably being more compliant than an upper cuff portion of the hybridretrieval bag 20″ described with respect to FIGS. 11-13).

In some embodiments, the cuff 130′, 130″ can include various complianceenhancing features. Increasing the compliance of the cuff 130′, 130″facilitates the opening and closure of the retrieval bag 20″ and enablesretrieval bag 20″ to be formed from a film material with a greaterthickness than would otherwise be possible in a comparable non-hybridretrieval bag. Increasing the compliance of the cuff also enablesretrieval bag to be formed from a material with a higher modulus thanwould otherwise be possible. Increasing the retrieval bag materialmodulus and/or thickness improves the tensile strength of the retrievalbag.

In various embodiments, the cuff 130′, 130″ can include one or more ofvarious compliance enhancing features such as holes 130′ (FIG. 14),slots 130″ (FIG. 15), slits, or notches in the cuff to provide the cuffwith increased compliance. In some embodiments, the compliance enhancingfeatures can be die cut into an otherwise solid cuff during manufactureof the retrieval bag. In other embodiments, other manufacturingtechniques can be used to form the compliance enhancing features.

In one method of manufacture, the cuff of the retrieval bag 20″ can beformed by folding the film at the open end of the retrieval bag over onitself and joining the film to itself such as by an adhesive bonding,thermal welding, or ultrasonic welding process. This folded and joinedsegment of film forms a cuff channel bounded by two film walls. Aclosure member and retrieval bag supports can pass through the cuffchannel. As described above, in use, after the retrieval bag supportsare withdrawn from the cuff channel, the cord loop is then tensioned andthe cuff channel is forced to fold longitudinally thereby cinching thebag closed. In various embodiments, the holes, slots, slits, or notchescan be formed through one or both of the walls of the cuff channel toprovide a desired degree of compliance.

It is contemplated that various configurations and arrangements ofcompliance enhancing features can be included in various embodiments ofhybrid retrieval bag 20″ having a compliant cuff. In some embodiments,the compliance enhancing features are provided circumferentiallythroughout the peripheral extent of the cuff. In other embodimentscompliance enhancing features are provided circumferentially over aportion of the peripheral extent of the cuff. For example, in theembodiments illustrated in FIGS. 14 and 15, a distal tip region of thecuff has no compliance enhancing features. In some embodiments,compliance enhancing features are provided throughout a depth of thecuff of the retrieval bag. In other embodiments, compliance enhancingfeatures are provided over a portion of the depth of the cuff of theretrieval bag. In some embodiments, compliance enhancing features are ofuniform size throughout the cuff portion. In other embodiments,compliance enhancing features vary in size along the cuff. For example,in some embodiments, at least some of the compliance enhancing featurescan be sized to prevent to prevent the retrieval bag supports fromprotruding through the wall of the cuff during deployment of theretrieval bag from the introducer tube.

In various embodiments of any of the above-described embodiments ofhybrid specimen retrieval bag, various aspects of the device can vary.For example, in certain embodiments, the retrieval bag can be formed ofone or more of a variety of materials, including polyurethane,polyethylene, polyimide, rip stop nylon®, polyester, and Mylar®.

While as discussed above with respect to FIG. 13, the hybrid retrievalbag 20″ can include a reinforced section at the distal-end portion 160″of the bag 20″, in other embodiments, any of the retrieval bagsdescribed herein the retrieval bag can be reinforced along the axis ofthe cord loop length and/or transverse to the axis of the cord loop tominimize the elongation of the bag during withdrawal from the bodycavity. For example, in various embodiments, a mesh material, strips ofa film material, strips of a woven fabric, cord, or wire can be attachedto the retrieval bag to reinforce the bag and prevent elongation anddeformation of the bag.

While as discussed above with respect to FIG. 11, the retrieval bag 20″can be formed of two portions 158, 160 of material having differentproperties, in some embodiments, the retrieval bag can be formed of morethan two portions of material each having different properties. Forexample, FIG. 11 illustrates a bag having a first material for the cuffportion with a relatively high compliance and a second material for thedistal portion having a relatively low compliance. In anotherembodiment, the retrieval bag can be formed from three or more differentfilm materials such that the cuff portion is formed of a low modulus,highly flexible material, an intermediate portion is formed of a mediamodulus, moderately flexible material, and the distal portion could beformed of a high modulus, relatively inflexible material.

Additionally, while FIG. 12 illustrates a tissue retrieval bag havingtwo portions of material having different thicknesses, in someembodiments, a retrieval bag is formed from three or more portions ofmaterial each having different thicknesses. For example, in someembodiments, the cuff portion is formed of a thin material, such as a 2mil thick film, the intermediate portion is formed of a moderately thickmaterial such as a 6 mil thick film, and the distal portion is formed ofa relatively thick material such as an 8 mil thick film.

Moreover, while FIG. 13 illustrates a retrieval bag having a reinforcedsection with an additional layer of film material at the distal end, inanother embodiment, a retrieval bag can have an intermediate portionhaving an intermediate level of reinforcement such as two layers of filmmaterial and relatively highly reinforced section at a distal endportion such as with three or more layers of film material.

In some embodiments, a hybrid retrieval bag can be formed of a singlefilm material which progressively increases in wall thickness from theproximal open end of the retrieval bag to the distal closed-end of theretrieval bag. In these embodiments, the retrieval bag canadvantageously have a relatively high strength at the closed end and arelatively high compliance at the open end.

As discussed above a tissue retrieval system having a hybrid tissueretrieval bag can be manufactured in a range of sizes and configurationsto accommodate varying clinical needs. In certain embodiments, thetissue retrieval systems can include a 5 mm diameter introducer tube toenable introduction through a 5 mm trocar. In other embodiments, atissue retrieval system can include a 10 mm introducer tube to enableintroduction through a 10 mm trocar. In other embodiments, a tissueretrieval system can include a 15 mm introducer to provide a largerretrieval bag for introduction through a 15 mm trocar.

In some embodiments, a hybrid tissue retrieval bag can be provided as astandalone device without introducer tube, handle, or delivery device.The hybrid retrieval bag, in this aspect, would be provided with aclosure member such as a cord loop. In use, the standalone tissueretrieval bag is rolled or folded by a surgeon and then advanced througha trocar into a body cavity with the use of a laparoscopic grasper. Insome embodiments, the standalone retrieval bag can be provided with aguide bead to enable the retrieval bag to be cinched closed and reopenedwithin the body cavity as necessary. In other embodiments, thestandalone retrieval bag could be provided with a slipknot in the cordloop to enable the retrieval bag to be cinched closed within the bodycavity.

Although this application discloses certain preferred embodiments andexamples, it will be understood by those skilled in the art that thepresent inventions extend beyond the specifically disclosed embodimentsto other alternative embodiments and/or uses of the invention andobvious modifications and equivalents thereof. Further, the variousfeatures of these inventions can be used alone, or in combination withother features of these inventions other than as expressly describedabove. For example, while various lengths and ratios of depths arediscussed with respect to the hybrid specimen retrieval bag of FIG. 11,it is contemplated that these descriptions are equally applicable to thehybrid retrieval bags of FIGS. 7-8 and 12-13. Thus, it is intended thatthe scope of the present inventions herein disclosed should not belimited by the particular disclosed embodiments described above, butshould be determined only by a fair reading of the claims pursued in anon-provisional application claiming priority hereto.

What is claimed is:
 1. A tissue retrieval device comprising: a retrievalbag having an open end and a closed end, the retrieval bag having afirst portion adjacent the open end, a second portion adjacent theclosed end, and a joint coupling the first portion to the secondportion; wherein the first portion of the retrieval bag has a firstcompliance and the second portion of the retrieval bag has a secondcompliance, the first compliance being greater than the secondcompliance.
 2. The tissue retrieval device of claim 1, wherein the firstportion of the retrieval bag comprises a first material, and the secondportion of the retrieval bag comprises a second material different fromthe first material.
 3. The tissue retrieval device of claim 1, whereinthe first portion of the retrieval bag has a first thickness, and thesecond portion of the retrieval bag has a second thickness differentfrom the first thickness.
 4. The tissue retrieval device of claim 3,wherein the second thickness is greater than the first thickness.
 5. Thetissue retrieval device of claim 4, wherein the first portion comprisesa first thickness of approximately 4 mil, and the second portioncomprises a thickness of approximately 6 mil.
 6. The tissue retrievaldevice of claim 1, wherein the first portion comprises a single layerand the second portion comprises a first layer and a second layercoupled to the first layer at the joint.
 7. The tissue retrieval deviceof claim 1, wherein the first portion comprises a first material havinga first modulus of elasticity and the second portion comprises a secondmaterial having a second modulus of elasticity greater than the firstmodulus of elasticity.
 8. The tissue retrieval device of claim 7,wherein the first material comprises a polyurethane film material havinga first modulus of elasticity of about 950 psi at 100% elongation, andthe second material comprises a polyurethane film material having asecond modulus of elasticity of about 1600 psi at 100% elongation. 9.The tissue retrieval device of claim 1, wherein the joint comprises atleast one of a welded connection, a bonded connection, and a sewnconnection.
 10. The tissue retrieval device of claim 1, wherein theretrieval bag comprises at least one of a polyurethane film, apolyethylene film, a polyimide film, ripstop Nylon®, polyester, andMylar®.
 11. The tissue retrieval device of claim 1, wherein the firstportion of the retrieval bag comprises a cuff adapted to receive atleast one support member therein.
 12. The tissue retrieval device ofclaim 1, further comprising a cord positioned in the first portion andoperable to selectively close the open end of the bag.
 13. The tissueretrieval device of claim 12, wherein the first portion comprises a cuffhaving a passage therein and the cord is positioned in the passage. 14.A tissue retrieval device comprising: a thin film bag having an open endand a closed end, the thin film bag comprising a first portion adjacentthe open end and a second portion adjacent the closed end, the firstportion and the second portion formed of a film material; wherein thefirst portion of the thin film bag has a first thickness and the secondportion of the thin film bag has a second thickness, the first thicknessbeing less than the second thickness.
 15. The tissue retrieval device ofclaim 14, wherein the thin film bag comprises a joint coupling the firstportion and the second portion.
 16. The tissue retrieval device of claim14, wherein the joint comprises at least one of a welded connection, abonded connection, and a sewn connection.
 17. The tissue retrievaldevice of claim 14, wherein the ratio of the first thickness to thesecond thickness is approximately 2:3.
 18. A tissue retrieval devicecomprising: a tissue bag having an open end, a closed end, and aninterior, the tissue bag comprising: a first portion adjacent the openend; and a second portion adjacent the closed end, the second portioncomprising: a first layer; a second layer; a space between the first andsecond layer; and at least one vent fluidly coupling the space toambient conditions exterior to the tissue bag.
 19. The tissue retrievaldevice of claim 18, wherein the second portion comprises a jointcoupling the first layer and the second layer.
 20. The tissue retrievaldevice of claim 19, wherein the vent comprises a gap in the joint. 21.The tissue retrieval device of claim 18, wherein the vent comprises atleast one hole in one of the first layer and the second layer.
 22. Atissue retrieval device comprising: a tissue bag having an open end anda closed end, the tissue bag comprising a cuff portion adjacent the openend; a first body portion between the cuff portion and a second bodyportion; and the second body portion adjacent the closed end; whereinthe cuff portion has a first compliance; the first body portion of thetissue bag has a second compliance and the second body portion of thetissue bag has a third compliance, the first compliance greater than thesecond compliance, and the second compliance greater than the thirdcompliance.
 23. The tissue retrieval device of claim 22, wherein thecuff portion comprises at least one cuff tab.
 24. The tissue retrievaldevice of claim 23, wherein the cuff portion comprises two cuff tabs.25. The tissue retrieval device of claim 22 wherein the second bodyportion comprises a reinforcing section.
 26. The tissue retrieval deviceof claim 22, wherein the first body portion comprises a first materialand the second body portion comprises a second material different fromthe first material.
 27. The tissue retrieval device of claim 22, whereinthe first body portion comprises a first thickness and the second bodyportion comprises a second thickness different from the first thickness.